Hazard

Foreign Body recalls

124 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 124
Critical: 2
Severe: 21
Most recent: 2026-03-18

Of the 124 foreign body recalls we have scored against our rubric, 2 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 21 (17%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all foreign body recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

101–124 of 124

CriticalFDA (Devices)·Z-0308-2017·2016-11-16
Ev3 Neurovascular Alligator Retrieval Device Recalled for Coating Defect
Micro Therapeutics Inc. is recalling 3,337 Alligator Retrieval Devices because the PTFE coating may delaminate and detach, potentially entering the bloodstream.
Product
Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No. FA-88810-20V04 FA-88810-20V06 FA-88810-30V04 FA-88810-30V06 FA-88810-40V04 FA-88810-40V06 FA-88810-50V04 FA-88810-50V06
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0307-2017·2016-11-16
FDA Recalls Pipeline Embolization Devices Due to Coating Delamination
Micro Therapeutics Inc is recalling Pipeline Embolization Devices because PTFE coating may delaminate and enter the bloodstream.
Product
Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 year of age or older) with large or giant widenecked intracranial aneurysms (lAs) in the internal carotid artery from the petrous to the superior hypophyseal sege
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0310-2017·2016-11-16
Ev3 Neurovascular Recalls X-Celerator Hydrophilic Exchange Guidewires
Micro Therapeutics Inc is recalling X-Celerator Hydrophilic Exchange Guidewires because PTFE coating delamination may release material into the bloodstream.
Product
X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 103-0602-350V09 103-0601-300V02 103-0602-300V01 103-0602-350V10 103-0601-300V03 103-0602-300V02 103-0601-300V06 103-0602-300v06 103-06
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0309-2017·2016-11-16
Ev3 Neurovascular Recalls Marathon and UltraFlow Micro Catheters
Micro Therapeutics Inc. is recalling Marathon and UltraFlow HPC Flow Directed Micro Catheters because PTFE coating may delaminate and enter the bloodstream.
Product
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0124-2017·2016-10-26
X Spine Systems Recalls Calix P PEEK Lumbar System PLIF Rasps
X Spine Systems Inc is recalling 182 units of Calix P PEEK Lumbar System PLIF Rasps because the tools may detach and become lodged in the surgical site.
Product
Calix P PEEK Lumbar System, PLIF Rasp
Category
Medical Device
Distribution
19 states
HighFDA (Devices)·Z-2240-2016·2016-07-27
Biomet Recalls TSP Hip Fracture Plating System Due to Screw Fracture Risk
Biomet, Inc. is recalling 5,458 units of the TSP Hip Fracture Plating System because screws may fracture during implantation, potentially leaving a foreign body in the patient.
Product
TSP Hip Fracture Plating System device, fixation, proximal femoral, implant The Biomet Hip Fracture Plating Systems are indicated for use in the open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures and intertrochante
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0422-2016·2015-12-30
Aesculap Flexible Screw Driver Recalled Due to Potential Shaft Breakage
Aesculap, Inc. is recalling 37 Flexible Screw Driver SJ706R units because the flexible shaft may break during surgery, posing a risk of fragments remaining in patients.
Product
Flexible Screw Driver SJ706R; Non Sterile; B Braun; Aesculap; Aesculap AG These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0423-2016·2015-12-30
Aesculap Flexible Bone Awl Recalled for Potential Shaft Breakage
Aesculap, Inc. is recalling 41 Flexible Bone Awls (SJ607R) because the flexible shaft may break during surgery, posing a risk of fragments remaining in patients.
Product
Flexible Bone Awl; SJ607R; NON STERILE; B Braun Aesculap; Aesculap AG: These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2359-2015·2015-08-19
Synthes Recalls 8.5mm Reamer Heads for Potential Intraoperative Breakage
Synthes (USA) Products LLC is recalling 8.5mm Reamer Heads for Flexible Intramedullary Nailing Systems due to the possibility of intraoperative breakage and un-retrieved material fragments.
Product
8.5mm Reamer Head for Flexible Intramedullary Nailing System; An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue or for use with other devices in orthopedic surgery. This generic type of device includes the
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1834-2015·2015-07-01
Stryker Recalls Fios First Entry Trocars Due to Fracture Risk
Stryker is recalling Fios First Entry trocars because some may fracture at the distal tip, leaving fragments at the surgical site.
Product
Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal proce
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1831-2015·2015-07-01
Stryker Recalls SERFAS 90 Degree Energy Probes Due to Fragmentation
Stryker Endoscopy is recalling 22,063 SERFAS 90 degree Energy Probes because fragments of the probe have been reported to break off into patients during arthroscopic procedures.
Product
SERFAS 90 degree Energy Probe, Part Number 279-350-101; SERFAS Energy Probes are indicated for arthroscopic procedures of the knee, shoulder, ankle, hip, elbow and wrist. Specifically, the probes are used for resection, ablation and coagulation of soft tissue, as well as the h
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1835-2015·2015-07-01
Stryker Recalls Optical Access Systems Due to Fracture Risk
Stryker is recalling specific Optical Access Systems because they may fracture at the tip, leaving fragments at the surgical site.
Product
Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdomina
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1836-2015·2015-07-01
Stryker Recalls Trocars Due to Reported Fracture at Distal Tip
Stryker is recalling specific cannula and seal models because they may fracture at the tip, leaving fragments at the surgical site.
Product
Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal proc
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0853-2015·2014-12-31
Zimmer Recalls Persona Cemented Tibial Broach Inserter/Extractor Handles
Zimmer, Inc. is recalling 83 units of Persona Cemented Tibial Broach Inserter/Extractor Handles because the magnet cover may disassociate and be lost during surgery.
Product
Persona Cemented Tibial Broach Inserter/Extractor. The Persona Cemented Tibial Broach Inserter/Extractor Handle is a Use sterilizable instrument intended for use In multiple TKA procedures. The Persona Surgical Technique indicates that the Persona Cemented Tibial Broach Insert
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-0038-2015·2014-10-15
DePuy Orthopaedics Recalls RECLAIM Distal Reamer Extension Devices
DePuy Orthopaedics is recalling 875 units of RECLAIM Distal Reamer Extension devices because the tabs may break and leave fragments in the patient.
Product
RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment device to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal.
Category
Medical Device
Distribution
27 states
SevereFDA (Devices)·Z-1467-2013·2013-06-12
FDA Recalls Versaport Bladeless Optical Trocars Due to Seal Disengagement Risk
The FDA is recalling 2,716 units of Versaport Bladeless Optical Trocars because seals may disengage, potentially causing components to enter the patient's cavity.
Product
Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long Product Code: ONB5LGF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entr
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1470-2013·2013-06-12
FDA Recalls Versaport Bladeless Optical Trocars Due to Seal Disengagement Risk
The FDA is recalling 5,364 units of Versaport Bladeless Optical Trocars because seals may disengage, potentially allowing components to enter the patient's cavity.
Product
Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm Product Code: ONB5STF2C The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of e
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1472-2013·2013-06-12
FDA Recalls Versaport Bladeless Optical Fixation Cannulas Due to Seal Disengagement
The FDA is recalling Versaport Bladeless Optical Fixation Cannulas because seals may disengage, potentially causing components to enter the patient's cavity.
Product
Versaport Bladeless Optical Fixation Cannula - 5mm Product Code: ONBFCA5ST The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1469-2013·2013-06-12
Recall of Versaport Bladeless Optical Trocar Due to Seal Disengagement
FDA Class II recall of 126,925 Versaport trocars because seals may disengage, risking component entry into the patient's cavity.
Product
Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Product Code: ONB5STF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1471-2013·2013-06-12
FDA Recalls Versaport Bladeless Optical Fixation Cannulas Due to Seal Disengagement
The FDA is recalling Versaport Bladeless Optical Fixation Cannulas because seals may disengage, potentially causing components to enter the patient's cavity.
Product
Versaport Bladeless Optical Fixation Cannula - 5mm Short Product Code: ONBFCA5SH The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0971-2013·2013-03-27
DePuy Specialist 2 IM Rod Recalled for Potential Breakage Risk
DePuy Orthopaedics is recalling Specialist 2 IM Rods and associated surgical techniques due to a potential risk of the rod breaking and leaving fragments in patients.
Product
Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma HP Instruments Classic Surgical Technique,0612-89-510 Sigma HP Instruments Balanced Surgical Technique, 0612-88-510 Sigma HP Instruments Fixed Reference Surgical Technique, 0612-87-510 PFC Sigma Knee
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0649-2013·2013-01-16
California Medical Laboratories Recalls Sterile Rigid Tip Suction Wands
California Medical Laboratories is recalling sterile rigid tip suction wands because the distal tip may detach and fall into a patient's chest cavity during surgery.
Product
Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the surgical field.
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-0534-2013·2012-12-26
Arobella Medical 6mm Qurette Recalled for Fracture Risk During Use
Arobella Medical is recalling 6mm Qurettes used in the AR1000 Wound Therapy System because they can fracture during use and release fragments.
Product
Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System. Major components of the AR1000 Wound Therapy System include an ultrasonic generator, converter hand piece, done-shaped applicator tip (qurette), and a saline supply reservoir. Product
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0453-2013·2012-12-12
OmniGuide BP-ROBOTIC Fiber Recalled Due to Glue Joint Failure
OmniGuide, Inc. is recalling 45 units of BP-ROBOTIC single-use fibers because a glue joint failure may cause the device to shift and fall into the patient.
Product
OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The OmniGuide Fiber is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general
Category
Medical Device
Distribution
Distributed nationwide